Prophylactic Use of Sodium Enoxaparin for Venous Thromboembolism in High-Risk Abdominal Surgery

Venous Thromboembolism Clinical Trial

Official title:

A Non-Inferiority Study of Enoxaparin Cristalia in Relation With Enoxaparin Sanofi-Aventis for Prophylaxis Against Venous Thromboembolism in Patients With High-Risk to Develop Thromboembolic Disease Undergoing Geral Abdominal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01308528
• Other study ID #: CRT062
• Status: Completed
• Phase: Phase 3
• First received: March 1, 2011
• Last updated: July 18, 2017
• Start date: February 2015
• Est. completion date: April 2017

Study information

• Verified date: July 2017
• Source: Cristália Produtos Químicos Farmacêuticos Ltda.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the safety and security and efficacy of sodium enoxaparin Cristália Produtos Químicos Farmaceuticos Ltda - Endocris with Clexane (Sanofi-Aventis) to prevent Venous Thromboembolism in Patients With High-Risk to Develop Thromboembolic Disease Undergoing Geral Abdominal Surgery.

Description:

This study is a requirement of Anvisa to add a new indication for off-label drug

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: April 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and women aged above 18 years undergoing abdominal surgery with general high risk for developing venous thromboembolism;

• Who have provided their consent by signing the consent form.

Exclusion Criteria:

• Clinical evidence of Venous thromboembolism (VTE) in the selection;

• treatment requirement with anticoagulant Low Molecular Weight Heparin, Unfracted Heparin, oral anticoagulant

• suspicion or history of coagulumpathia

• Heparin, enoxaparin allergy or hypersensitiviy known to heparin, enoxaparin, but not restrict to thrombocytopenia and/or induce thombose by heparin ou enoxaparin (thrombocytopenia induce by heparin [TIH], thrombocytopenia associate with heparin [TAH] or thrombotic thrombocytopenia syndrome induce by heparin [STTIH]

• Active bleeding that can be increased by enoxaparin.

• Previous history of known intracranial hemorrhage

• Artery-venous malformation or a suspicion or known cerebral aneurism

• Spinal, Epidural ou lumbar puncture analgesia in the last 24 hours previous of the first dose of the administration of the enoxaparin.

• erosive diseases of the digestive tract especially gastroduodenal

• Uncontrolled hypertension (systolic blood pressure [BP]> 180mmHg or diastolic BP> 100 mm Hg) at randomization or clinical hypertensive urgency;

• bacterial endocarditis

• heart valve prosthesis

• characterized by severe renal insufficiency creatinine clearance <30 ml / min

• Intra-arterial thrombolic therapy

• Thrombolic therapy within 24 hours.

• Low Molecular Weight Heparin or Unfraction Heparin treatment with prophylactic dose over 48 hours before surgery or oral anticoagulant within 5 days before surgery

• disturbance of consciousness and coma

• Less than 6 months of expectative time life

• Chemical dependency

• Patient with anesthetic risk ASA III or ASA IV

• morbid obesity with Body Mass Index = 40

• Chronic use of corticosteroids

• History of allergy to Unfraction Heparin, Low molecular weight heparin or pork products.

• History of severe allergic episode, systemic anaphylaxis, or major urticarial disease Steven-Johnson

• Participation in another clinical study within 12 months prior to inclusion

• Potentially fertile woman without ß-HCG negative harvested until 48 hours before operation or not using acceptable contraception for participation in this study

• Changes the security checks up to 48 h before randomization:

• Hemoglobin <10 mg / dL;

• ALT or AST = 2.5 times ULN;

• Platelet count <100.000/mL;

• INR = 1.5;

• Any condition which in the opinion of the investigator, could lead to increased risk for the patient or who makes it inappropriate for this study.

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Sodium enoxaparin
40 mg/mL
• Sodium Enoxaparin clexane
clexane 40 mg/ 0,4 mL

Locations

Country	Name	City	State
Brazil	Hospital Regional da Asa Norte	Brasília	DF
Brazil	Fundação de Desenvolvimento da Unicamp - FUNCAMP	Campinas	São Paulo
Brazil	Huning Instituto de Oftalmologia e Pesquisa HIOP/HRPC	Canoas	Rio Grande do Sul
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul
Brazil	Hospital São Lucas da PUCRS	Porto Alegre	Rio Grande do Sul
Brazil	Hospital das Clínicas de Riberião Preto	Ribeirão Preto	São Paulo
Brazil	Hospital Estadual Mario Covas	Santo Andre	São Paulo
Brazil	Centro Multidisciplinar de Estudos Clínicos	Sao Bernardo do Campo	São Paulo
Brazil	Fundação Faculdade Regional de Medicina de São José do Rio Preto	São Jósé do Rio Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Cristália Produtos Químicos Farmacêuticos Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Sodium enoxaparin to demonstrate non-inferiority	Evaluation of Prophylactic use of Sodium enoxaparin to demonstrate non-inferiority for Venous Thromboembolism in High-Risk Surgery in Abdominal	10 Days
Secondary	Safety of sodium enoxaparine	comparision between Endocris (sodium enoxaparin - Cristalia Prod. Quim. Farm.) versus Clexane (sodium enoxaparine - Sanofi-Aventis) in High-Risk Abdominal Surgery.	10 days
Secondary	Compare the incidence of venous thromboembolism and pulmonar embolism	Compare the incidence of venous thromboembolism and pulmonar embolism between 2 groups after 30 days of surgery	10 days